Correction factor testing using frequent blood glucose input

• US 7,734,323 B2
• Filed: 01/24/2007
• Issued: 06/08/2010
• Est. Priority Date: 01/24/2007
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: Pope, Rhall E., Blomquist, Michael
• Primary Examiner(s): Nasser; Robert L
• Application Number:
  US11/626,653
• Publication Number:
  US 20080177165A1
• Time in Patent Office: 1,231 Days
• Field of Search: 600/365, 604/65
• US Class Current: 600/347
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

An apparatus comprising a user interface configured to generate an electrical signal to begin determination of an effective correction factor when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration after delivery of an initial insulin correction bolus, and a controller in electrical communication with the input and the user interface. The controller includes a correction factor module configured for determining an effective correction factor according to an amount of insulin in the initial insulin correction bolus and a decrease in the blood glucose level determined using the sampled blood glucose data. Other devices and methods are disclosed.

Claims

1. An apparatus comprising:

a user interface configured to generate an electrical signal to begin determination of an effective correction factor when prompted by a user, wherein the determination of the effective correction factor includes delivery of an initial correction bolus;

an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration after delivery of the initial insulin correction bolus; and

a controller communicatively coupled to the input and the user interface, the controller including a correction factor module configured to;

calculate an effective correction factor using an amount of insulin in the initial insulin correction bolus and a decrease in the blood glucose level determined by the controller using the sampled blood glucose data; and

cancel the determination of the effective correction factor if a blood glucose level of the patient is outside of a specified range of blood glucose levels.

2. The apparatus of claim 1, wherein the controller further includes an insulin calculation module configured for estimating, using a pre-bolus correction factor, the amount of insulin in the initial insulin correction bolus to decrease a blood glucose level of the patient to within a first specified percentage of a target blood glucose baseline.

3. The apparatus of claim 2, wherein the insulin calculation module is configured for receiving the pre-bolus correction factor that is manually entered by a user through the user interface.

4. The apparatus of claim 2, wherein the insulin calculation module is configured for receiving daily injection information entered by a user through the user interface and to estimate the pre-bolus correction factor using the daily injection information.

5. The apparatus of claim 2, wherein the insulin calculation module is configured for determining the amount of insulin in the initial insulin correction bolus using a blood glucose level and a rate of change of the blood glucose level of the patient.

6. The apparatus of claim 2, further including:

a pump mechanism configured for delivering the initial insulin correction bolus to the patient, wherein the pump mechanism is operatively coupled to the controller; and

a blood glucose monitor communicatively coupled to the input.

7. The apparatus of claim 6, wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data.

8. The apparatus of claim 6, further including:

a display in electrical communication with the controller, and

wherein the controller is configured for prompting the user, via the display, to begin a blood glucose measurement using the blood glucose monitor.

9. The apparatus of claim 2, further including:

a pump mechanism operatively coupled to the controller to deliver the insulin correction bolus to the patient,

wherein the insulin calculation module is further configured for determining an amount of active insulin in the patient, and to determine the initial insulin correction bolus amount using the amount of active insulin.

10. The apparatus of claim 1, wherein the controller includes an insulin calculation module configured to:

estimate, using a pre-bolus correction factor, the amount of insulin in the initial insulin correction bolus to decrease a blood glucose level of the patient to within a first specified percentage of a target blood glucose baseline; and

determine an amount of carbohydrates for the patient to consume if the blood glucose level of the patient is below a target blood glucose level.

11. The apparatus of claim 10, wherein the insulin calculation module is further configured for determining the amount of carbohydrates using a blood glucose level and a rate of change of the blood glucose level of the patient.

12. The apparatus of claim 1, further including:

a pump mechanism configured for delivering the insulin correction bolus to the patient, wherein the pump mechanism is operatively coupled to the controller; and

wherein the user interface and the input are configured to receive the sampled blood glucose data entered manually by the user.

13. The apparatus of claim 12, further including:

a display in electrical communication with the controller, wherein the controller is configured for displaying user instructions for the determination of the effective correction factor, including periodically prompting the user to enter a blood glucose value.

14. The apparatus of claim 1, further including:

a timer circuit; and

a display, wherein the timer circuit and the display are operatively coupled to the controller, and wherein the controller is configured for displaying user instructions to determine the effective correction factor at one or more specified times during a day.

15. The apparatus of claim 14, wherein the controller is configured for displaying user instructions to determine the effective correction factor during a substantially same time on multiple days.

16. The apparatus of claim 1, further including a display in electrical communication with the controller, and wherein the controller is configured for displaying the effective correction factor.

17. The apparatus of claim 1, wherein the input is a first input and the apparatus further includes:

a blood glucose sensor circuit operatively coupled to the first input, the blood glucose sensor circuit configured to produce a blood glucose signal representative of a blood glucose level of the patient and provide the sampled blood glucose data to the first input;

a second input in electrical communication with the controller, wherein the second input is configured to receive information related to insulin delivery, including an amount of active insulin, if any, and the pre-bolus correction factor; and

wherein the correction factor module determines the effective correction factor using the insulin delivery information and the sampled blood glucose data.

18. The apparatus of claim 17, further including a communication port coupled to the second input, the communication port to receive the information related to insulin delivery.

19. The apparatus of claim 18, wherein the controller is configured for communicating the effective correction factor through the communication port.

20. The apparatus of claim 17, wherein the user interface and the second input are configured to receive the information related to insulin delivery that is entered manually by the user.

21. The apparatus of claim 1, wherein the input includes at least one communication port configured for receiving the sampled blood glucose information and to receive information related to insulin delivery, including an amount of active insulin, if any, and the pre-bolus correction factor, wherein at least one of the sampled blood glucose information and the information related to insulin delivery includes a time-stamp, and

wherein the correction factor module determines the effective correction factor using the information related to insulin delivery, the sampled blood glucose data, and the time-stamp.

22. The apparatus of claim 21, wherein the controller is configured for communicating the effective correction factor through the communication port.

23. An apparatus comprising:

a user interface configured to generate an electrical signal to begin determination of an effective correction factor when prompted by a user;

an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration after delivery of the initial insulin correction bolus; and

a controller communicatively coupled to the input and the user interface, the controller including;

a correction factor module configured to calculate an effective correction factor using an amount of insulin in the initial insulin correction bolus and a decrease in the blood glucose level determined by the controller using the sampled blood glucose data; and

an insulin calculation module configured to;

estimate, using a pre-bolus correction factor, the amount of insulin in the initial insulin correction bolus to decrease a blood glucose level of the patient to within a first specified percentage of a target blood glucose baseline; and

determine, using the effective correction factor, a second insulin correction bolus having an amount of insulin to decrease the blood glucose level of the patient to within a second specified percentage of the target blood glucose baseline.

24. The apparatus of claim 23, wherein the controller is configured to cancel determining the effective correction factor if a blood glucose level of the patient is outside of a specified range of blood glucose levels.

25. An apparatus comprising:

a user interface configured to generate an electrical signal to begin determination of an effective correction factor when prompted by a user;

an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration after delivery of the initial insulin correction bolus; and

a controller communicatively coupled to the input and the user interface, the controller including;

a correction factor module configured to calculate an effective correction factor using an amount of insulin in the initial insulin correction bolus and a decrease in the blood glucose level determined by the controller using the sampled blood glucose data; and

an insulin calculation module configured for estimating, using a pre-bolus correction factor, the amount of insulin in the initial insulin correction bolus to decrease a blood glucose level of the patient to within a first specified percentage of a target blood glucose baseline; and

a pump mechanism configured for delivering the insulin correction bolus to the patient, wherein the pump mechanism is operatively coupled to the controller;

wherein the insulin calculation module is further configured for determining an amount of active insulin in the patient, and wherein the controller is configured to cancel the effective correction factor determination if the active insulin amount is above a specified threshold amount.

26. The apparatus of claim 25, wherein the controller is configured to cancel determining the effective correction factor if a blood glucose level of the patient is outside of a specified range of blood glucose levels.

27. An apparatus comprising:

means for receiving a user prompt in a BG management device to start a determination of an effective correction factor;

means for receiving sampled blood glucose data of a patient obtained during a specified time duration, including a time duration after delivery of an initial insulin correction bolus; and

means for calculating the effective correction factor with the BG management device using a determined decrease in the blood glucose level of the patient and the amount of insulin in the initial insulin correction bolus; and

means for cancelling the determination of the effective correction factor if a blood glucose level of the patient is outside of a specified range of blood glucose levels.